1. Field of the Invention
The invention relates to the field of intrauterine contraceptive devices, now popularly known as "IUD's" and specifically to a tubular inserter useful for insertion of any one of a wide variety of IUD's.
2. Discussion of the Prior Art
Background information concerning female contraceptive agents in general and the distinct advantages of the intrauterine device or IUD over other contraceptive agents is set forth in detail in U.S. Pat. Nos. 3,633,574 and 3,771,520, identified above.
One of the few remaining factors retarding even more widespread acceptance and use of the IUD as a contraceptive agent is the experience of IUD insertion. The development of satisfactory IUD insertion means, readily adaptable to a wide variety of currently popular IUD's will be an important contribution to the art. Such insertion means must firmly engage the IUD during insertion through the cervical canal and positioning in the fundal region of the uterine cavity, yet be easily disengaged therefrom for withdrawal of the inserter. An inserter should be manipulable by one hand only since the other hand of the person performing the insertion will be employed in moving the uterus from its normal anteflexed position to a state of traction whereby the IUD may be easily inserted; this is accomplished by grasping the cervical anterior lip with a tenaculum and exerting a pulling force.
Preferably, IUD's are dispensed as a prepackaged, sterilized assembly with the IUD in place on the inserter so that upon breaking the sterile seal, the device is immediately ready for insertion. A most popular form of inserter is a relatively narrow diameter tube having a rounded, blunt end which will pass through the cervical canal easily and will not damage or injure the fundus upon contact therewith. Such tubes as currently marketed contain a resilient IUD which is deformed into a narrow elongate shape within the tube so that the assembly is ready for immediate use. Once expulsed from the insertion tube within the uterine cavity, the IUD is supposed to resume its normal, undeformed expanded shape.
Unfortunately, the period of time from packaging to use may be quite extended, and the IUD may lose its resilient nature thereby becoming permanently deformed and unable to spring back into its planned expanded configuration once positioned within the uterine cavity. To date, the only answer to the problem has been to package the IUD and its tubular inserter in unattached fashion. This solution yields two unsatisfactory results. First, unnecessary handling is required to assemble the unit prior to insertion, such handling being inherently time-consuming and potentially destructive of the sterile environment of the IUD and its inserter. Secondly, the handler may put the unit together incorrectly thereby either irretrievably jamming the IUD within its tubular inserter, or injuring the cervical canal and uterine cavity in attempting to insert an improperly mounted IUD.
U.S. Pat. No. 3,515,132 issued to Charles A. McKnight recognizes the problem of shelf life deterioration of an IUD packaged in a deformed condition, but provides no solution other than to package the IUD separately from the tubular inserter. The tubular inserter disclosed in the patent includes a lateral port adjacent an internal plunger for frictionally engaging an IUD withdrawal cord during insertion, but the tubular inserter is specifically not designed to enter the uterine cavity, nor does the lateral tube port cooperate in any manner in housing the IUD in a normal, expanded configuration.
In contradistinction, the present invention provides a tubular inserter which is packaged with the IUD housed therein in its normal expanded condition. Immediately prior to insertion, the IUD is easily deformed into a compressed shape within the tube and readily expulsed therefrom into its normal, expanded configuration within the uterine cavity. Thus, prolonged deformation of the IUD is avoided, which considerably lengthens the shelf life of such items.
The inserter of the present invention is adaptable for use with a wide variety of IUD's. For example, it may be used with the type of IUD disclosed in the aforenoted U.S. Pat. No. 3,633,574; with open end IUD's, two of which are known in the art as the T and the 7; with closed loop IUD's such as the Birnberg bow; and with IUD's having a plurality of extended winglike projections for engaging side walls of the uterine cavity to aid in preventing expulsion of the IUD therefrom. The T-form of IUD is disclosed in U.S. Pat. No. 3,533,406, issued to Howard J. Tatum, and the Birnberg bow is fully disclosed in U.S. Pat. No. 3,230,953, issued to Charles H. Birnberg.